Quality of life in a trial of short stretch versus four-layer bandaging in the management of chronic venous ulceration

Abstract

Objective: To evaluate health-related quality of life (HRQoL) in a prospective randomized trial of patients suffering from venous ulceration comparing a generic four-layer elastic bandage (4LB) with a new cohesive short stretch bandage system (CSSB).

Methods: Randomized prospective open parallel groups trial in community leg ulcer clinics within twelve trusts in England and Northern Ireland. Patients newly presenting for treatment suffering from chronic venous ulceration, with ankle brachial pressure index (ABPI) >0.8 were entered into the trial. Patients were asked to complete the Nottingham Health Profile (NHP) at entry, at end of trial period (withdrawal or healing), and at 24 weeks. Principal analysis was the comparison of final NHP scores using linear regression with baseline scores entered as a covariate.

Results: In all, 154 of the 156 patients who entered the trial completed the initial questionnaire, with 139/154 (90.2%) patients completing at least one follow-up questionnaire. Improvements were noted for all scores after 24 weeks. The improvements were significantly greater in the 114 patients whose ulcers had healed compared with the 40 whose ulcers remained open in the domains of bodily pain (mean difference [d]=13.2, 95% CI 3.6-22.9, P =0.008), emotional reactions (d=10.5, 95% CI 2.8-18.1, P =0.007) and social isolation (d=8.5, 95% CI 1.2-15.9, P =0.024). There were similar mean scores between the 72 patients treated with the 4LB and the 82 patients treated with CSSB for all domains of the NHP, the largest adjusted difference favoured CSSB for energy (d=3.6, 95% CI-4.3-11.4, P =0.37).

Conclusions: Patients suffering from leg ulceration show improvements in perceived health following effective ulcer management. The two bandage systems achieved similar improvements in perceived health over 24 weeks.